China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with a sustained economic and population growth, Chinese healthcare market has maintained an annual average growth rate above 16% since 1990s. By 2013, total value of drugs on the Chinese healthcare market has reached RMB 1114 billion. On the Chinese healthcare market, imported drugs made by overseas and multinational pharmaceutical manufacturers account for about one fourth. It is estimated that the total value of drugs on the Chinese healthcare market will be likely to be more than 1450 billion RMB by 2015, and will surpass Japan to become the second largest drug market following the United States. The Chinese healthcare market will attract more and more overseas pharmaceutical manufacturers and producers to penetrate such market.

However, when searching for the website of the Chinese regulatory authority of drugs, China Food and Drug Administration, you may find there are many announcements of adverse drug reaction reports for those drugs made by overseas and multinational pharmaceutical manufacturers. How to report an adverse drug reaction market and event to the Chinese regulatory authorities? Who should report adverse drug reaction and event to the Chinese regulatory authorities? How do the Chinese regulatory authorities monitor the adverse drug reaction and event reporting? How to comply with Chinese regulations for adverse drug reaction reporting and monitoring? A series of questions are facing overseas and multinational pharmaceutical manufacturers. The overseas and multinational pharmaceutical manufacturers and their senior executive officers engaging in regulatory affairs need a comprehensive and thorough knowledge of the Chinese regulations for adverse drug reaction reporting and monitoring. The regulations on adverse drug reaction reporting and monitoring between China and US-EU are different. Moreover, the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas and multinational pharmaceutical manufacturers and producers.

Report Highlights:

Chinese general regulations for adverse drug reaction and event reporting and monitoring, and the special regulations for adverse drug reaction and event reporting and monitoring of overseas manufacturers of imported drugs in the Chinese drug market.

The detailed Chinese regulations for the manufacturer’s duty for adverse drug reaction and event reporting, from the responsibilities and obligations, the operation procedures of adverse drug reaction and event reporting, the control and evaluation for adverse drug reaction, the focal point monitoring for drugs, the special regulations for reporting serious adverse event occurred outside of the territory of China to an entire process of adverse drug reaction and event reporting for manufacturer to guide agents within the territory of China designated by overseas and multinational pharmaceutical manufacturers to smoothly handle complex regulatory requirements step by step, because they must be in compliance with these regulations. Browse complete Table of Contents @ http://www.marketreportsonline.com/321345-toc.html.